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- MiscellaneousMiscellaneous
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- MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus3Product Code
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- MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm3Product Code
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- PCYInvestigational Use Only - MicrobiologyNProduct Code
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- Submissions with No Product CodeMiscellaneous
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- P050028COBAS AMPLIPREP/COBAS TAQMAN HBV TESTOK30PMA Approval
- P050028COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0OK30PMA Approval
- P050028COBAS AMPLIPREP/COBAS TAQMAN HBV TESTOK30PMA Approval
- P050028COBAS TAQMAN HBV TESTOK30PMA Approval
- P050028COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEMOK30PMA Approval
- P050028COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEMOK30PMA Approval
- P050028COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEMOK30PMA Approval
- P050028COBAS TAQMAN HBV TESTOK30PMA Approval
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- P990045DIASORIN ETI-AB-COREK PLUS ASSAYAPPRPMA Approval
- P990041DIASORIN ETI-AB-EBK PLUS ASSAYAPPRPMA Approval
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- P940034AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TESTAPPRPMA Approval
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- K833027HAEMOPHILUS/NEISSERIA IDENTIF-PANELCleared 510(K)
- K833214DEXTROSECleared 510(K)
- K832934MACCONKEY'S AGAR PLATECleared 510(K)
- K830646DIRECTIGEN NEISSERIA MENINGITIDISCleared 510(K)
- K822518CSM BETA-LACTAMASE DISCCleared 510(K)
- K820208ZYME ACleared 510(K)
- K812123CYTOMEGELISA TEST KITCleared 510(K)
- K800052ANTIMICROBIAL REMOVAL DEVICE (ARD)Cleared 510(K)
- K781283READER, INOCULUM, STDIZED.Cleared 510(K)
- K781097INOCULUM STDIZING SYS., INOCUPACCleared 510(K)
- K780114IMMUNOZYME E. HISTOLYTICA ANTIGENSCleared 510(K)
- K771569AUTOSTREAKERCleared 510(K)
- K760356DISH, STERILE DISPOSABLE POLYSTYRENECleared 510(K)
- K760583DISPOSABLE/BOROSILICATE CULTURE TUBESCleared 510(K)
- N17578INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC)APPRPMA Approval
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Roche Molecular Systems, Inc.
- Trade Name
- COBAS TAQMAN HBV TEST
- Generic Name
- Hepatitis Viral B DNA Detection
- Decision Date
- 9/4/2008
- Days to Decision
- 1129 days
- Decision Code
- APPR
- FDA Decision
- Approval